A study to assess the efficacy of an emollient cream in reducing skin reactions of patients treated for their Actinic Keratosis with 5- fluorouracil 4% treatment

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Frequency and Intensity of local reactions in patients treated with 4% 5-FU vs 4% 5-FU associated with an emollient cream: a randomised, controlled clinical trial

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Status
Status :
Completed
Type of study
Phase IV
Min. Age
18
Years old
Max. Age
-
Gender
All

Brief summary

Actinic Keratosis (AK) treatments such as topical 5-fluorouracil formulations induced frequent local skin reactions. These reactions are temporary and are a normal response to treatment but can lead some patients to discontinue the therapy. The purpose of this study is to evaluate if the use of the emollient cream Dexeryl® may reduce skin reactions of patients treated with Tolak® for their Actinic Keratosis.

Therapeutic area :
Dermatology
Disease :
Actinic keratosis
Study medication :
5-fluorouracil 4% (TOLAK®)
Phase : Phase IV
Start Date :
16 February 2021
End Date / Planned study Completion Date :
31 January 2022
Study ID : W00118CR401
EudraCT/CTIS number : 2020-000851-11
CT.gov Number : NCT04875026
Countries :
France
Germany
Italy
Spain

Find out where the clinical trial was conducted

1

No Information

Kesselschmiedstraße 2
85354 Freising
Germany

2

No Information

Haifa-Allee 20
55128 Mainz bretzenheim
Germany

3

Instituto Valenciano de Oncología

Carrer del Professor Beltrán Báguena, 8
46009 Valencia
Spain

4

Hospital Marina Baixa

Av. Alcalde En Jaume Botella Mayor, 7
03570 Villajoyosa alicante
Spain

5

HOSPITAL UNIVERSITARIO INFANTA LEONOR

C/ GRAN VIA DEL ESTE 80
28031 Madrid
Spain

6

Complejo Hospitalario Universitario Juan Canalejo

Calle Santiago Rey Fernández Latorre 114 Bajo
15006 A coruna
Spain

7

Centro de Salud Algorta

Calle Bidezabal 30
48993 Getxo vizcaya
Spain

8

Centre medic Congres

Carrer de Pardo, 8-12
08027 Barcelona
Spain

9

University of Modena and Reggio Emilia

Via Del Pozzo 71
41100 Modena
Italy

10

University of Messina

Viale S. Martino, 367
98125 Messina
Italy

11

UNI CLINIC L’AQUILA

Via Vetoio (Coppito 2, Edificio "Angelo Camillo De Meis")
67100 Coppito
Italy

12

NAPLES VANVITELLI UNIVERSITI (Federico II Hospital)

University of Campania Nuovo Policlinico (edificio 9C), Via Pansini 5
80131 Naples
Italy

13

UNI CLINIC BRESCIA

ASST Spedali Civili di Brescia Piazzale Spedali Civili 1
25123 Brescia
Italy

14

Centro Oncologico ad Alta Tecnologia Diagnostica

Viale Risorgimento 80
42123 Reggio emilia
Italy

15

MVZ Dermatologisched Zentrum Bonn GmbH,

Friedensplatz 16
53111 Bonn
Germany

16

Kath. Klinikum Bochum St. Josef-Hospital

Gudrunstr. 56
44791 Bochum
Germany

17

Hautarztpraxis

Annenstrasse 151
58453 Witten
Germany

18

CentroDerm Clinic

Heinz-Fangman-Straße 57
42287 Wuppertal
Germany

19

Dermatologikum Hamburg

Stephanplatz. 5
20354 Hamburg
Germany

20

Pharmacie du CHU de Poitiers _ Essais cliniques

Rue de la Milétrie
86000 Poitiers
France

21

Centre Médical Saint-Jean

8 Square Saint Jean
62000 Arras
France

22

Centre Hospitalier de PAU

4 BD HAUTERIVE
64000 Pau
France

23

CHU DE NANTES

HÔTEL-DIEU- HME 1 Place Alexis Ricordeau
44000 Nantes
France

24

CHU St Etienne Hopital Nord

25, boulevard Pasteur
42055 Saint etienne
France

Last update at : 09 September 2024

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